• Serve as the owner and the champion of company QMS• Maintain ISO9001 compliance and support RC 14001 certification • Manage supplier approval process• Manage internal audit program, perform internal audits• Manage and assure implementation of CAPA resulting from internal and external nonconformances, audits and complaints, insure completion and effectiveness of corrective actions • Improve process documentation to facilitate consistency and adherence to quality system requirements • Collect and use data to develop quality initiatives to support continual improvement

• Consult production sites in implementation of ISO 9001:2015 QMS, Automotive and Electronic customer QMS, and Company Global QMS. Write site QMS procedures and supports their implementation. • Work on preparation and execution site level ISO certifications. Communicate with registrar bodies. • Lead and participate in root cause analyses (5Why, root cause mapping, 8D) of customer complaints and other non-conformances, and support sites in corrective action implementations. Manage complaints process. • Collect and analyze quality KPI, prepare monthly reports for the management. Acts on opportunities for improvement. Review quality KPI with production sites on a monthly basis. Prepare, organize, and conduct management review meetings. • Contribute to mindset change toward customer centricity by continuous support and coaching of sites and business functions on customer complaints management tool and emphasizing their role in the process. • Prepare quality documents for electronic and automotive customers, complete customer surveys and questionnaires, and work with commercial and technical support teams on customer interactions. • Manages internal audit program, performs internal audits and supplier audits based on criticalities.• Prepare sites for and support them during customer and other external audits, and ensure closure of audit findings, internal nonconformities, and customer complaints.

Promoted to this role to report directly to the president to support the improvement of quality and compliance to internal IMS/QMS and external regulatory agencies, and report the status to upper management. - Successfully identified gaps and non-compliance, and facilitated continuous improvement that aligned with business strategies and operations. - Served as the Lead Auditor for QMS audits, and managed audit program for the organization.- Supported management in key decision-making processes by analyzing compliance status of the organization and provides recommendations to management (corporate and plant) on compliance activities and training initiatives. - Contributed to internal and external compliance by proactively identifying a gap in the training that resulted from a major change in operations; secured approval from the CEO to facilitate a $150K project that took 7 weeks and included 120 field employees. Project was completed on time and within the budget.-Aligned organization's standard operating procedures with the requirements of the Food Safety Modernization Act (FSMA)

Brought on to support continuous improvement efficiencies and compliance and support the organization’s management in various process improvement projects - Identified a field-technicians retention problem, conducted comparative analysis in the job market, and created a proposal to management with a new recruitment strategy which was implemented and resulted in shorter cycle from a vacancy to onboarding a new technician. - Discovered opportunities for continuous improvement, assessed quality and compliance key performance indicators, prepared reports for senior management, analyzed trends and proposed actions to improve efficiencies. - Increased efficiencies and transparency in information sharing by implementing Google Drive document sharing - Recommended and trained the organization in the use of tablet to increase efficiency and maintain data integrity in redlining the P&IDs.

Promoted to this position for self initiative and assumed more responsibility: - Decreased training delinquencies by 90% during 2013 by evaluating training patterns of the organization, and reorganized organizations’ training set up in the electronic system of record (Smart Solve), which resulted in increased training transparency to the end user for future training, and contributed to improving operations throughout the organization. - Reduced time needed for field technicians to become effective and independent in field and improved the safety culture by creating a training and qualification program which included, in addition to instruction, simulation area to practice field scenarios; and encouraged them to share best practices. - Developed an easy-to-use-and-maintain tracking system for documenting training and qualification activities; coached 11 field managers to adopt and utilize.

Entrusted to manage education of field managers and employees regarding the company’s quality management system (QMS). Additionally responsible for developing tools to support field engineers in ensuring efficiency and productivity in their daily. Monitored operations to identify opportunities for continuously improving quality and compliance.- Managed and supported the closure of documentation for 120 management of change (MOCs) instances, and 90 Quality incidents from 2008-2010 IMS audits within the first year on the position.- Bridged communication gaps between internal departments to resolve non-compliance identified during audits; designed a new workflow and management process for completing crucial field documentation that was acceptable for all parties. - Prepared a manual for field managers on safety, technical excellence and company’s industrial management system. Initiated and managed meetings focused on best practice sharing.

Assured facility’s FDA compliance for medical gas and devices in all aspects, and was responsible for employee training, writing standard operating procedures, record keeping, production control, product analysis, medical product release. - Responsible for medical product analysis, evaluation, interpretation and verification of analytical data, and complete FDA compliance for the plant. Reinforced cGMP with plant employees. -Ensured FDA compliance by setting up in the electronic system of records equipment and maintenance schedules for 4 plants. Implemented cGMP, HSES&Q and technical procedures and standards.

Supported management in assuring new and existing Air Liquide facilities, equipment, systems and processes were properly validated in accordance with FDA and international food, drug, and medical device standards and regulations. - Monitored FDA and industry organizations for regulatory changes and guidance pertinent to validation activities and medical quality.- Developed and executed validation protocols for medical gas and device filling systems , analytical methods and instrumentation.